LensHooke Liquefaction Enzyme CK1

GUDID 04719874741259

BONRAYBIO CO., LTD.

Specimen preparation enzyme reagent IVD

• Primary Device ID: 04719874741259
• NIH Device Record Key: 26240205-cb27-4ae0-955e-ef1cd3047c68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LensHooke Liquefaction Enzyme
• Version Model Number: CK1 Package-10pcs-BR USA CORP.
• Catalog Number: CK1
• Company DUNS: 658872369
• Company Name: BONRAYBIO CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719874741259 [Primary]

FDA Product Code

• IBG: Trypsin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-21
• Device Publish Date: 2025-02-13

Devices Manufactured by BONRAYBIO CO., LTD.

• 04719874741259 - LensHooke Liquefaction Enzyme: 2025-02-21
• 04719874741259 - LensHooke Liquefaction Enzyme: 2025-02-21
• 04719874741297 - LensHooke Semen Quality Analyzer: 2025-02-21
• 04719874742614 - LensHooke X QC Slide (For Semen): 2025-02-21
• 04719874742621 - LensHooke X QC Slide (For Semen): 2025-02-21
• 04719874742638 - LensHooke X QC Slide (For Semen): 2025-02-21
• 04719874742669 - LensHooke X QC Slide (For Semen): 2025-02-21
• 04719874740702 - LensHooke Semen Quality Analyzer: 2022-09-16
• 14719874741591 - LensHooke Sperm DNA fragmentation test kit (SCD assay): 2021-11-26